Zonisamide Capsules, 50 mg Capsules, Packaged in 100 Count Bottles, Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-0946-01.

Class I - Dangerous
💊 Drugs Recalled: April 22, 2015 Wockhardt Usa Prescription Drugs Nationwide

What Should You Do?

  1. Check if you have this product:
    Lot #: LM10769, Expiry: 4/30/2015; Lot #: LM10770, Expiry: 4/30/2015; Lot #: LM10771, Expiry: 4/30/2015; Lot #: LM10875, Expiry: 5/31/2015; Lot #: LM10876, Expiry: 5/31/2015; Lot #: LM11145, Expiry: 6/30/2015; Lot #: LM11174, Expiry: 6/30/2015; Lot #: LM11175, Expiry: 6/30/2015; Lot #: LM11226, Expiry: 7/31/2015; Lot #: LM11227, Expiry: 7/31/2015; Lot #: LM11289, Expiry: 7/31/2015; Lot #: LM11290, Expiry: 7/31/2015; Lot #: LM11544, Expiry: 8/31/2015; Lot #: LM11545, Expiry: 8/31/2015; Lot #: LM11671, Expiry: 9/30/2015; Lot #: LM11947, Expiry: 10/31/2015; Lot #: LM11948, Expiry: 10/31/2015; Lot #: LM11949, Expiry: 10/31/2015; Lot #: LM11950, Expiry: 10/31/2015; Lot #: LN10208, Expiry: 12/31/2015; Lot #: LN10209, Expiry: 12/31/2015; Lot #: LN10210, Expiry: 12/31/2015; Lot #: LN10211, Expiry: 12/31/2015; Lot #: LN10212, Expiry: 12/31/2015; Lot #: LN10213, Expiry: 12/31/2015; Lot #: LN10354, Expiry: 1/31/2016; Lot #: LN10355, Expiry: 1/31/2016; Lot #: LN10526, Expiry: 2/29/2016; Lot #: LN10527, Expiry: 2/29/2016; Lot #: LN10528, Expiry: 2/29/2016; Lot #: LN10529, Expiry: 2/29/2016; Lot #: LN10541, Expiry: 2/29/2016; Lot #: LN10840, Expiry: 4/30/2016; Lot #: LN11113, Expiry: 5/31/2016; Lot #: LN11333, Expiry: 7/31/2016; Lot #: LN11377, Expiry: 8/31/2016.
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Wockhardt Usa Inc.
Reason for Recall:
CGMP Deviations: Firm did not adequately investigate customer complaints.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

Zonisamide Capsules, 50 mg Capsules, Packaged in 100 Count Bottles, Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-0946-01.

Product Codes/Lot Numbers:

Lot #: LM10769, Expiry: 4/30/2015; Lot #: LM10770, Expiry: 4/30/2015; Lot #: LM10771, Expiry: 4/30/2015; Lot #: LM10875, Expiry: 5/31/2015; Lot #: LM10876, Expiry: 5/31/2015; Lot #: LM11145, Expiry: 6/30/2015; Lot #: LM11174, Expiry: 6/30/2015; Lot #: LM11175, Expiry: 6/30/2015; Lot #: LM11226, Expiry: 7/31/2015; Lot #: LM11227, Expiry: 7/31/2015; Lot #: LM11289, Expiry: 7/31/2015; Lot #: LM11290, Expiry: 7/31/2015; Lot #: LM11544, Expiry: 8/31/2015; Lot #: LM11545, Expiry: 8/31/2015; Lot #: LM11671, Expiry: 9/30/2015; Lot #: LM11947, Expiry: 10/31/2015; Lot #: LM11948, Expiry: 10/31/2015; Lot #: LM11949, Expiry: 10/31/2015; Lot #: LM11950, Expiry: 10/31/2015; Lot #: LN10208, Expiry: 12/31/2015; Lot #: LN10209, Expiry: 12/31/2015; Lot #: LN10210, Expiry: 12/31/2015; Lot #: LN10211, Expiry: 12/31/2015; Lot #: LN10212, Expiry: 12/31/2015; Lot #: LN10213, Expiry: 12/31/2015; Lot #: LN10354, Expiry: 1/31/2016; Lot #: LN10355, Expiry: 1/31/2016; Lot #: LN10526, Expiry: 2/29/2016; Lot #: LN10527, Expiry: 2/29/2016; Lot #: LN10528, Expiry: 2/29/2016; Lot #: LN10529, Expiry: 2/29/2016; Lot #: LN10541, Expiry: 2/29/2016; Lot #: LN10840, Expiry: 4/30/2016; Lot #: LN11113, Expiry: 5/31/2016; Lot #: LN11333, Expiry: 7/31/2016; Lot #: LN11377, Expiry: 8/31/2016.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-1273-2015

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